A protocol exceeded the patch:
Regarding the patch, the protocol Bullen study was to provide vouchers to participants for pharmacy patches to 21 mg of nicotine, without seeing a doctor first to explain their proper use nor answer their questions.
Thereafter, the dose patch was the same for all participants who were heavy smokers and roasting on average 18 cigarettes per day for over 20 years.
Today dose patch is adapted to the signs of lack, some patients need several patches to be relieved. Especially, it combines oral forms of nicotine gum, tablets, lozenges, inhalers or sprays, so that patients can relieve their signs missing in the day. It may for example prescribe a patch per day to 21 mg and 4 mg gum at will, which gums a day for 15 gives 80 mg with 21 mg nicotine patch.
This is equivalent to 4 times the dose of nicotine that taken by the participants of the study Bullen. Worse, they have been provided patches for 3 months without medical supervision, while in practice, nicotine substitutes are prescribed as much time as necessary.
These differences between the current good clinical practice and the study protocol, very simply why the patches were not more effective than placebo in the publication of Professor Bullen.
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